Zilbrysq (zilucoplan) — Medica

Initial criteria

• age ≥ 18 years
• confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
• Myasthenia Gravis Foundation of America classification II to IV
• Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6
• received or is currently receiving pyridostigmine OR had inadequate efficacy, contraindication, or significant intolerance to pyridostigmine
• received or is currently receiving two different immunosuppressant therapies for ≥ 1 year OR had inadequate efficacy, contraindication, or significant intolerance to two different immunosuppressant therapies (examples: azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus, cyclophosphamide)
• evidence of unresolved symptoms of generalized myasthenia gravis (e.g., difficulty swallowing, difficulty breathing, functional disability such as double vision, talking, or mobility impairment)
• prescribed by or in consultation with a neurologist

Reauthorization criteria

• age ≥ 18 years
• according to prescriber, patient is continuing to derive benefit from Zilbrysq (e.g., reductions in exacerbations of myasthenia gravis; improvements in speech, swallowing, mobility, or respiratory function)
• prescribed by or in consultation with a neurologist

Approval duration

initial: 6 months; reauthorization: 1 year